 |
|
FDA ignores critical information on home HIV tests
May 29, 2009The FDA is ignoring critical information in deciding whether to approve an over-the-counter, rapid HIV test for home use, according to a recent article in the journal Medical Decision Making (MDM) which is published by SAGE.
As the price of the HIV test rises, some lower-income individuals who are at greater risk for HIV infection will not be able to afford it. The FDA has been criticized because it bases its decisions on small studies performed in non-representative populations.
"When approving new technologies, the FDA should focus less on the general population and more on the people who will actually use these technologies," said co-author A. David Paltiel, PhD, of the Yale School of Medicine. "The disconnect between approved indication and actual use is stark."
The test in question is the OraQuick ADVANCE 1/2, a rapid, point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes using a simple cheek swab. The test is already FDA-approved for use in health care settings such as hospitals, drug treatment facilities, state and local health departments, clinics, community-based organizations, and university health centers throughout the United States.
The FDA has asked the manufacturer to collect data on the ability of the test to correctly detect both the presence and absence of HIV infection when employed by untrained users. However, it has not requested any further information on how the manufacturer's retail price will influence the demand for home testing in populations with high-rates of undetected HIV infection. Using a mathematical analysis, the authors demonstrate that many of the highest-risk individuals will be unable to afford home testing at the price the manufacturer is likely to propose. By failing to take into account the relationship between retail pricing, consumer purchasing behavior, and HIV risk, the FDA may overestimate the test's ability to identify previously undetected cases of HIV infection.
"The information currently sought by the FDA is not sufficient to address the true benefit of the HIV test for home use," write Paltiel and co-author Harold A. Pollack, PhD of the University of Chicago School of Social Service Administration. "Our analysis suggests that a cheaper test may do a better job of finding HIV infection. The home HIV test product might actually work better at a lower price."
SAGE Publications
The test in question is the OraQuick ADVANCE 1/2, a rapid, point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes using a simple cheek swab. The test is already FDA-approved for use in health care settings such as hospitals, drug treatment facilities, state and local health departments, clinics, community-based organizations, and university health centers throughout the United States.
The FDA has asked the manufacturer to collect data on the ability of the test to correctly detect both the presence and absence of HIV infection when employed by untrained users. However, it has not requested any further information on how the manufacturer's retail price will influence the demand for home testing in populations with high-rates of undetected HIV infection. Using a mathematical analysis, the authors demonstrate that many of the highest-risk individuals will be unable to afford home testing at the price the manufacturer is likely to propose. By failing to take into account the relationship between retail pricing, consumer purchasing behavior, and HIV risk, the FDA may overestimate the test's ability to identify previously undetected cases of HIV infection.
"The information currently sought by the FDA is not sufficient to address the true benefit of the HIV test for home use," write Paltiel and co-author Harold A. Pollack, PhD of the University of Chicago School of Social Service Administration. "Our analysis suggests that a cheaper test may do a better job of finding HIV infection. The home HIV test product might actually work better at a lower price."
SAGE Publications
HIV Current Events and HIV News RSSUniversity of Michigan scientists identify chemical in bananas as potent inhibitor of HIV infection
A potent new inhibitor of HIV, derived from bananas, may open the door to new treatments to prevent sexual transmission of HIV, according to a University of Michigan Medical School study published this week.
University of Michigan scientists discover bone marrow can harbor HIV-infected cells
University of Michigan scientists have identified a new reservoir for hidden HIV-infected cells that can serve as a factory for new infections.
How to fortify the immunity of HIV patients
New findings from a Université de Montréal and the Vaccine and Gene Therapy Institute of Florida (VGTI) study, in collaboration with scientists from the NIH and the McGill University Health Center, may soon lead to an expansion of the drug arsenal used to fight HIV.
Periodontal pathogens enhance HIV-1 promoter activation in T cells
Today, during the 39th Annual Meeting of the American Association for Dental Research, convening at the Walter E. Washington Convention Center in Washington, DC, lead researcher O.A. Gonzalez (University of Kentucky, Lexington) will present a poster of a study titled "TLR2 and TLR9 Activation by Periodontal Pathogens induce HIV-1 Reactivation."
HIV Vaccine Strategy Expands Immune Responses
Two teams of researchers-including Los Alamos National Laboratory theoretical biologists Bette Korber, Will Fischer, Sydeaka Watson, and James Szinger-have announced an HIV vaccination strategy that has been shown to expand the breadth and depth of immune responses in rhesus monkeys. Rhesus monkeys provide the best animal model currently available for testing HIV vaccines.
Neutrons poised to play big role in future scientific advances
Subatomic particles called neutrons are poised to play a big role in fighting HIV, slowing global warming, and improving manufacturing processes.
Innate immune mechanisms can control disease progression in HIV-positive patients
HIV/AIDS remains one of the world's most significant public health challenges, particularly in developing countries. The Human Immunodeficiency Virus (HIV-1), the variant responsible for the pandemic, has the ability to infect different cell types such as T cells, macrophages and dendritic cells (DC).
Health care volunteers and disasters: First, be prepared
A surge in volunteers following a major disaster can overwhelm a response system, and without overall coordination, can actually make a situation worse instead of better.
Biologists use mathematics to advance our understanding of health and disease
Math-based computer models are a powerful tool for discovering the details of complex living systems. John Tyson, professor of biology at Virginia Tech, is creating such models to discover how cells process information and make decisions.
Keys and obstacles to e-health in low income countries
In an essay in the February 2010 issue of Health Affairs, a special issue of the journal devoted to global e-health, William Tierney, M.D., of Indiana University School of Medicine and the Regenstrief Institute, and colleagues, who like Dr. Tierney have significant experience in the development of workable health information technology systems in low-income countries, identify critical steps toward allowing developing countries to cross the "digital divide" to realize the full potential of e-health to improve the quality and efficiency of their health care systems.
More HIV Current Events and HIV News Articles
 |
HIV Essentials 2010 by Paul E. Sax (Author), Calvin J. Cohen (Author), Daniel R. Kuritzkes (Author) HIV Essentials 2010 incorporates the latest clinical guidelines into a step-by-step guide to the diagnosis, evaluation, management and prevention of HIV infection and its complications. Topics include: HIV diagnosis, evaluation, treatment and prevention; Opportunistic infections and other HIV Complications; Treatment of HIV and pregnancy; Antiretroviral drug summaries; Post-exposure Prophylaxis; New section to each drug summary called "How Supplied" describes the commercially available dosage forms for all the ARV's |
 |
The First Year: HIV: An Essential Guide for the Newly Diagnosed by Brett Grodeck (Author), M.D. Daniel S. Berger M.D. (Foreword) This supportive resource explores the next generation of HIV/AIDS drugs and also includes new research on HIV and crystal meth, as well as new insights for the hardest hit population — African Americans. |
 |
100 Questions and Answers About HIV and AIDS by Joel Gallant (Author) |
 |
Living with HIV: A Patient's Guide by Mark Cichocki (Author) This helpful guide offers a wealth of information for individuals who have been diagnosed with HIV and for people caring for HIV positive friends and loved ones. It covers the entire HIV lifespan, from prevention to diagnosis and beyond. Valuable tips help the reader make the best decision when choosing a doctor, finding and adhering to the right medication regimen, and, if necessary, making end-of-life plans. All aspects of HIV/AIDS are discussed, including opportunistic and associated infections, dental care, exercise and nutrition, substance use and abuse, and emotional treatment. |
 |
Healing HIV: How To Rebuild Your Immune System by Jon D., M.D. Kaiser (Author), Jon D. Kaiser (Author) |
 |
HIV and the Pathogenesis of AIDS, 3rd Edition by Jay A. Levy (Author) The new edition of HIV and the Pathogenesis of AIDS provides a state-of-the-art review of the current research, explains the history of the disease, and examines how scientists, clinicians, and public health workers have responded to the challenges presented by HIV/AIDS in the 25 years since its recognition. Many exciting developments in the field have deepened scientific understanding of HIV/AIDS and have provided novel approaches for prevention and treatment. The book explores potential approaches for therapy and a vaccine for the prevention of HIV infection and AIDS is discussed. Thoroughly updated and revised, the third edition continues to provide a comprehensive analysis of the subject that is unmatched in the field. Figures and tables illustrate and emphasize key points and... |
 |
The Naked Truth: Young, Beautiful, and (HIV) Positive by Marvelyn Brown (Author), Courtney Martin (Author) The surprisingly hopeful story of how a straight, nonpromiscuous, everyday girl contracted HIV and how she manages to stay upbeat, inspired, and more positive about life than ever before At nineteen years of age, Marvelyn Brown was lying in a stark white hospital bed at Tennessee Christian Medical Center, feeling hopeless. A former top track and basketball athlete, she was in the best shape of her life, but she was battling a sudden illness in the intensive care unit. Doctors had no idea what was going on. It never occurred to Brown that she might be HIV positive. Having unprotected sex with her Prince Charming had set into swift motion a set of circumstances that not only landed her in the fight of her life, but also alienated her from her community. Rather than give... |
 |
HIV/AIDS: A Very Short Introduction (Very Short Introductions) by Alan Whiteside (Author) HIV/AIDS is without doubt the worst epidemic to hit humankind since the Black Death. As of 2004 an estimated 40 million people were living with the disease, and about 20 million had died. Despite rapid scientific advances there is still no cure and the drugs are expensive and toxic. In the developing world, especially in parts of Africa, life expectancy has plummeted to below 35 years, causing a serious decline in economic growth, a sharp increase in orphans, and the imminent collapse of health care systems. The news is not all bleak though. There have been unprecedented breakthroughs in understanding diseases and developing drugs. Because the disease is so closely linked to sexual activity and drug use, the need to understand and change behavior has caused us to reassess what it means... |
 |
Medical Management of HIV Infection by M.D. John G Bartlett (Author), M.D., M.P.H. Joel E. Gallant (Author), Pharm. D. Paul A.Pham (Author), Johns Hopkins University School of Medicine (Author) |
 |
Nutrition and HIV: A New Model for Treatment by Mary Romeyn M.D. (Author) Treating HIV with Nutrition Nutrition and HIV addresses the issues of nutrition and HIV from the perspective of the patient as well as the physician. Everyone who is interested in the problems of--and solutions to--nutritional therapy in HIV owes it to themselves to read this book. This reference book offers a sound nutritional model for sustaining and improving quality of life for HIV positive men and women. It outlines an easy-to-follow program for the prevention and treatment of weight loss--a common problem that if left untreated could lead to serious health decline or even death. |
| © 2010 BrightSurf.com |